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Completed

NCT Number: NCT00670904

Randomized Trial Assessing the Effectiveness of a Pharmacist-Delivered Program for Smoking Cessation

This randomized trial compared the effectiveness of a three session pharmacist-delivered group program for smoking versus one 5 to 10 minute standard care session delivered over the telephone on 7-day point prevalence quit rates. Participants in both groups were offered their choice of bupropion IR or nicotine patch at no cost. At 6 months after the established quit date, self-reported cessation was biochemically verified using tests for urinary cotinine.

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Key information

Conditions

Tobacco Use Disorder Behavior Chemically-Induced Disorders Health Behavior Mental Disorders Smoking Smoking Cessation Substance-Related Disorders

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Missoula VA Clinic

Missoula, Montana, 59808, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Smoked one or more cigarettes daily for 7 days
  • Somewhat ready to quit in the next 2 weeks (4 or more on a 10- point scale)
  • Willing and capable of attending three scheduled sessions at the clinic
  • Interested in participating in the study

Exclusion criteria

  • Planned to leave the area in the next 6 months
  • Used pharmacotherapy for smoking cessation in the last 30 days
  • Used other forms of tobacco in the last 30 days
  • Schizophrenia
  • Prior participation

Treatment and study plan

Pharmacist-delivered group program for smoking cessation

Other

Participants assigned to the treatment group participated in a pharmacist-delivered program at the clinic. The six-hour program consisted of three in-person sessions delivered at 2-week intervals over 5 weeks to a small group of smokers. Participants were offered their choice of one medication either bupropion IR or nicotine patch using doses and durations based on current medical practices. Participants receiving bupropion received a quantity sufficient to complete 12 weeks of therapy. Participants receiving nicotine patches received a quantity sufficient to complete 8 weeks of step-down therapy.

Brief standard care session for smoking cessation delivered over the telephone

Other

Those assigned to the control group received one 5 to 10 minute session delivered by the clinical pharmacist over the telephone that included all the components of standard care recommended by the Clinical Practice Guidelines for brief interventions delivered by health care providers. Participants were offered their choice of one medication either bupropion IR or nicotine patch using doses and durations based on current medical practices. Participants receiving bupropion received a quantity sufficient to complete 12 weeks of therapy. Participants receiving nicotine patches received a quantity sufficient to complete 8 weeks of step-down therapy.

Primary outcomes

  1. The primary outcome variable for the study was biochemically verified 7-day point prevalence smoking cessation at 6 months, defined as having smoked no cigarettes - not even a puff - for the previous 7 days.

    Time frame: 6 months

Secondary outcomes

  1. Secondary outcomes included 30-day point prevalence abstinence and prolonged abstinence (>6 months).

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University of Montana

Other

Collaborators

  • Prevent Cancer Foundation

Registry information

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
May 2, 2008
Registry last updated
Jan 12, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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